Physical Medicine and Rehabilitation Clinic, University Clinical Center of Kosovo (UCCK)
Pristina, Kosovo, 10000
NCT Number: NCT07736456
Brief Summary
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may progress during adolescence and lead to postural asymmetry, spinal rotation, pelvic imbalance, reduced spinal mobility, and decreased quality of life.
This randomized controlled trial aims to evaluate the effectiveness of a 16-week structured physiotherapeutic corrective exercise program compared with standard physiotherapy care in adolescents with mild to moderate AIS (Cobb angle 10°-40°).
Participants aged 10-18 years will be randomly assigned to either an experimental group or a control group using stratified block randomization based on age and baseline Cobb angle. The study will be conducted under the responsibility of the University of Prishtina- Faculty of Medicine and the University Clinical Center of Kosovo, with academic collaboration from Alma Mater Europaea.
The experimental group will receive a structured physiotherapeutic corrective exercise program including core stabilization, stretching, spinal self-correction, and pelvic correction exercises. The control group will receive standard physiotherapy exercises used in routine clinical practice.
Both groups will undergo supervised physiotherapy sessions three times per week for 16 weeks, with additional prescribed home exercises.
Primary outcomes include individual spinal alignment parameters assessed using the DIERS Formetric 3D/4D system, including lateral deviation angle and vertebral rotation. Secondary outcomes include additional postural alignment parameters, spinal mobility measured using an inclinometer, and health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.
Assessments will be performed at baseline, 8 weeks, and 16 weeks. Each outcome parameter will be analyzed separately to evaluate changes over time and differences between groups.
The study will provide evidence on whether a structured corrective physiotherapy program offers superior outcomes compared with standard physiotherapy care in adolescents with AIS.
Interested in participating?
Request Info10 year–18 year
All sexes
Interventional
Not applicable
Pristina, Kosovo, 10000
Detailed Description
This randomized controlled trial evaluates the effectiveness of a structured physiotherapeutic corrective exercise program in adolescents with mild to moderate idiopathic scoliosis (Cobb angle 10°-40°), compared with standard physiotherapy care.
Adolescent idiopathic scoliosis is a structural spinal deformity characterized by lateral curvature, vertebral rotation, and postural imbalance. It may also be associated with pelvic asymmetry, altered sagittal spinal alignment, reduced spinal mobility, and impaired health-related quality of life.
Despite evidence supporting physiotherapeutic scoliosis-specific exercises, limited research has investigated comprehensive exercise programs addressing spinal alignment, postural control, and pelvic-related impairments simultaneously using advanced three-dimensional postural assessment systems.
Participants aged 10-18 years will be recruited from the Physical Medicine and Rehabilitation Clinic at the University Clinical Center of Kosovo and the University of Prishtina - Faculty of Medicine. The study is conducted under ethical approval from relevant institutional ethics committees. Alma Mater Europaea serves as an academic collaborating institution.
Participants will be randomly allocated to an experimental or control group using stratified block randomization based on age and baseline Cobb angle. Outcome assessors and statisticians will be blinded to group allocation.
The experimental group will follow a 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spinal self-correction, and pelvic correction exercises. The control group will receive standard physiotherapy exercises commonly used in clinical practice for adolescent idiopathic scoliosis.
Both groups will receive supervised physiotherapy sessions three times per week for 16 weeks, each lasting approximately 45 minutes, and will perform additional home-based exercises two days per week.
Primary outcome measures will include individual spinal alignment parameters assessed using the DIERS Formetric 3D/4D Spine & Posture Analysis System, including change in lateral deviation angle and change in vertebral rotation. Each parameter will be analyzed as a separate outcome measure.
Secondary outcome measures will include individual postural and functional parameters assessed separately, including trunk imbalance, trunk inclination, pelvic obliquity, pelvic torsion, pelvic rotation, kyphotic angle, lordotic angle, spinal mobility measured using an inclinometer, and health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.
Measurements will be performed at baseline, 8 weeks, and 16 weeks. Statistical analysis will compare within-group and between-group changes over time using appropriate parametric and non-parametric tests, with statistical significance set at p < 0.05.
Additionally, agreement between angle of trunk rotation measured by scoliometer and vertebral rotation measured by the DIERS Formetric 3D/4D system will be evaluated as an exploratory analysis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spine autocorrection, and pelvic stabilization and correction exercises. Participants will attend supervised sessions three times per week and perform home exercises two additional days per week.
The Standard Physiotherapy Exercise Program will last 16 weeks and consists of conventional therapeutic exercises aimed at improving spinal strength, flexibility, posture, and coordination in adolescents with idiopathic scoliosis.
Time frame: Week 16
Change from baseline to Week 16 in lateral spinal deviation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in vertebral rotation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in trunk imbalance measured by the DIERS Formetric 3D/4D system. The outcome will be reported in millimeters (mm).
Time frame: Week 16
Change from baseline to Week 16 in trunk inclination measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in pelvic obliquity measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in pelvic torsion measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in pelvic rotation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in thoracic kyphotic angle measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in lumbar lordotic angle measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in spinal mobility measured using an inclinometer. The outcome will be reported in degrees (°).
Time frame: Week 16
Change from baseline to Week 16 in health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire. Scores range from 22 to 110, with higher scores indicating better health-related quality of life.
Alma Mater Europaea - Slovenia
Other
The Effect of a 16-Week Structured Physiotherapeutic Corrective Exercise Program on Lateral Spinal Deviation, Vertebral Rotation, and Pelvic Position in Mild and Moderate Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
Acronym: SPINE-AIS16
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07714993
Bone Diseases, Musculoskeletal Diseases
Gaziantep, Turkey (Türkiye)
View Trial DetailsNCT07681739
Behavior, Bone Diseases
Gaziantep, Turkey (Türkiye)
View Trial DetailsNCT07680374
Bone Diseases, Musculoskeletal Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07249502
Bone Diseases, Musculoskeletal Diseases
Istanbul, Turkey (Türkiye)
View Trial Details